Physician - Psychiatrist or Neurologist - Part-time

1 week ago

Richmond, Canada Headlands Research Full time

Overview:
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.

Richmond Clinical Trials is a satellite site to Okanagan Clinical Trials located in Kelowna, BC. Our clinic specializes in the execution of research studies that hope to advance treatments for many indications including Alzheimer’s disease, Parkinson’s disease, migraine, autism, celiac disease, diabetes, and more.

**The Role**

**Responsibilities**:

- Follow ICH-GCP, FDA CFR, Health Canada Division 5 guidelines, and OCT SOPs
- Work collaboratively with the entire research team
- Attend investigator meetings, site initiation meetings, and internal research meetings as assigned
- Ensure Protocol Compliance
- Possess a thorough understanding of the requirements of each clinical trial protocol
- Avoid protocol deviations or making any changes to protocol activities without agreement by the sponsor and prior review and approval by the REB (except to eliminate immediate hazard to the patient)
- Manage the Medical Care of the Research Subjects
- Possess familiarity with each clinical trial Investigator Brochure
- Assess patient compliance with protocol activities and study drug
- Evaluate and document adverse events
- Ensure provision of medical care and follow up as needed for adverse events
- Communicate in a timely manner with the medical monitor assigned by the sponsor to respond to and resolve any safety or eligibility concerns
- Protect the Rights and Welfare of Patients
- Report all serious adverse events and adverse events of special interest to the sponsor within 24 hours and to the REB when the event meets the REB’s reporting requirements
- Obtain a signed and dated informed consent form from the patient or patient’s legally authorized representative (LAR) prior to initiating any study-related procedures
- Inform the patient and/or LAR about all aspects of the clinical trial
- Provide new information about the study or study drug as it becomes available
- Ensure Documentation of Study-Related Procedures, Processes and Events
- Document deviations from the approved protocol
- Cooperate with site PI in the development of corrective and preventative action plans (CAPAs) as needed
- Document the informed consent process
- Document all adverse experiences with respect to AE term, causality, seriousness, and management
- Comply with written procedures to document changes to data and/or case report forms
- Ensure the Proper Use and Storage of Investigational Product
- Be familiar with the use of the investigational product
- Be familiar with the Investigators Brochure, product insert, and other sources of information regarding the study drug
- Clinical Care
- As part of recruitment initiatives and in conjunction with staff physicians, assess, diagnose and treat patients with neurological disorders

Qualifications:

- Active and unencumbered College of Physicians of BC (CPSBC) license to practice as an MD or DO within the district of BC required
- At least five years of experience practicing as a physician in Canada required
- Previous clinical research experience highly preferred

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